Trial Condition(s):

Contraception

YAZ, Oral Contraceptive registration in China

Bayer Identifier:

91619

ClinicalTrials.gov Identifier:

NCT00819312

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.

Inclusion Criteria
-Healthy women between 18 and 45
   requesting oral contraception. 
  -Smokers may not exceed 30 years of age.
Exclusion Criteria
-The use of steroidal oral contraceptives , or 
   any drug that could alter oral contraception 
   metabolism will be prohibited during the study.
  -Pregnancy, lactation (less than 3 menstrual 
   cycles since delivery, abortion or lactation 
   before start of treatment)
  -Menstrual disorders suspicious of ovarian
   failure (e.g. oligomenorrhea, amenorrhea, 
   hypomenorrhea
  -Any disease or condition that may worsen 
   under hormonal treatment
  -Other contraceptive methods such as 
   sterilization or IUD/IUS
  -Substantial overweight (BMI > 30 kg/m2).

Trial Summary

Enrollment Goal
675
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Peking University First Hospital

Beijing, China, 100034

Status
Completed
 
Locations

Chongqing Medical University Second Hospital

Chongqing, China, 400010

Status
Completed
 
Locations

Tongji Hosp Tongji Med College of Huazhong University of Sci

Wuhan, China, 430022

Status
Completed
 
Locations

Xijing Hospital, the 4th Military Medical University

Xi An, China, 710032

Status
Completed
 
Locations

Southeast University affilitated Zhongda Hospital

Nanjing, China, 210009

Status
Completed
 
Locations

The Obs. and Gyn. Hospital of Medical Center of Fudan Univer

Shanghai, China, 200011

Status
Completed
 
Locations

Shanghai second Medical University, Shanghai Ren Ji Hospital

Shanghai, China, 200127

Status
Completed
 
Locations

Peking University People's Hospital

Beijing, China, 100044

Status
Completed
 
Locations

West China Second University Hospital of Sichuan University

Chengdu, China

Status
Completed
 
Locations

1st hospital of Chongqing Medical University

Chongqing, China

Status
Completed
 
Locations

Shengjing Hospital of China Medical University

Shenyang, China, 110004

Status
Completed
 
Locations

Qi Lu hospital of Shandong University

Jinan, China

Status
Completed
 
Locations

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Status
Completed
 
Locations

Nanjing First Hopital

Nanjing, China, 210006

Status
Completed
 
Locations

Subei People's Hospital of Jiangsu Province

Yangzhou, China, 225001

Status
Completed
 
Locations

The Second Affiliated Hospital of Sun Yat-sen University

Guangzhou, China, 510120

Status
Completed
 
Locations

Queen Mary Hospital, University of Hong Kong

Hongkong, Hong Kong, China

Status
Completed
 

Trial Design